Lean Documents and Document Control

Just as a manufacturing process produces a product, controlled documents are the product of a business process. Just as in manufacturing, a product cannot move forward if it is waiting for component parts, a document cannot move forward if it is waiting for information, or if its use is constrained by other documents. Although many lifescience companies advocate lean manufacturing, lean laboratory, and lean operations, they have cumbersome controlled documents and systems which cause significant operating expenses, and make it difficult to introduce process improvements in a timely manner. This webinar presents key concepts on introducing lean principles, while maintaining a state of control and regulatory compliance.

Areas Covered in the seminar:

• Definition of lean documents
• Problems with traditional document approach
• Applying lean manufacturing principles
• Applying Theory of Constraints
• Design History File
• Device Master Record
• Device History Record

What Attendee Will Learn:

• Use of lean document principles; types of controlled documents; examples of lean and non-lean controlled documents. Pros and cons of lean vs. non-lean documents
• How traditional document approach generates waste
• Clues from Theory of Constraints and Lean Manufacturing
• What a lean document approach would have
• Creating a lean Design History File
• Creating a lean Device Master Record
• Creating a lean Device History Record
• Preparing for an electronic document system

Who Will Benefit:

This webinar will provide valuable insights to design engineers, manufacturing engineers, operations managers, quality system managers, and document control managers

• Project leaders implementing an electronic document system
• Functional managers
• QA managers
• Lean Project Managers

Instructor Profile:

Jose Mora, is a Sr. Consultant at Streale as well as a partner in Atzari Consulting, LLC. Although he has been in the medical device industry for 24+ years in various companies, he has observed that the same types of issues and principles apply in all cases. Jose has worked as a Director of Manufacturing, Director of Manufacturing Engineering, Sr. Manufacturing Engineer, and as a Quality Systems Manager at companies such as V. Mueller (Cardinal Health), Cordis Corporation (J&J), Mentor Corporation, UroSurge (a startup urology products company), Boston Scientific, as well as several consulting clients. Jose has a BS. in Mechanical Technology from Purdue University.

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